SAN MARINO, Calif., July 8 Epeius BiotechnologiesCorporation today announced that Rexin-G has been granted Orphan DrugDesignation by the U.S. Food and Drug Administration (FDA) for the treatmentof osteosarcoma. Based on several criteria, including the rarity,seriousness, and current lack of effective therapies for metastaticosteosarcoma, as well as the scientific and medicinal merit of Rexin-G, thegranting of Orphan Drug Status by the FDA validates the unique clinicaldevelopment strategy of Epeius Biotechnologies: that is, to demonstrate theprofound single-agent efficacy of Rexin-G where traditional treatments havehistorically failed.
The FDA Orphan Drug Act was designed to encourage the development of newproducts that demonstrate significant promise for the treatment of veryserious or life-threatening conditions that are relatively rare, affectingfewer than 200,000 persons in the United States. Orphan Drug Designationprovides important economic incentives and powerful market protections thatencourage the development of innovative products in the cancer field. U.S.Orphan Drug Designation provides seven years of market exclusivity forRexin-G, a reduction in fees and taxes, and additional regulatory support forR&D initiatives.
Rexin-G, the lead product of Epeius Biotechnologies, is the first in aseries of tumor-targeted anti-cancer agents designed to seek out andaccumulate in metastatic cancers that have spread throughout the body,delivering a lethal payload of genetic medicine to tumor cells and theirassociated blood supplies without harming normal cells, tissues, or organsystems. Specifically designed to function within the context of the humancirculatory system, the demonstration of single agent-efficacy by Rexin-G inStage IV or metastatic osteosarcoma (ASCO, 2008) is an indication of theremarkable clinical potential of the precision targeting technologies embodiedin its design. The Orphan Drug designation by the FDA represents an importantmilestone in the clinical development of Rexin-G for osteosarcoma.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceuticalcompany dedicated to the advancement of genetic medicine with the developmentand commercialization of its proprietary targeted delivery systems. To learnmore about our pipeline of proprietary biotechnologies that are currentlyavailable for licensing and clinical development, please visit us athttp://www.epeiusbiotech.com.
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SOURCE Epeius Biotechnologies